Viant AS&O Holdings, LLC

FDA Device Registration & Listing · LACONIA, NH, US · Registration 1221485

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1221485
FEI Number
1221485
Entity Name
Viant AS&O Holdings, LLC
City/State/Country
LACONIA, NH, US
Establishment Address
45 Lexington Dr, LACONIA, NH 03246, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Viant Medical, LLC (Owner Number: 9043339)
Owner / Operator Contact Address
2 Hampshire Street, Suite 202, Foxborough, MA 02035, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TELIGEN Procedure Kit Pro TELIGEN System Auris Biopsy Forceps (Monarch Endoscopy Platform) Disposable Biopsy Forceps - 2.2MM, 104CM UNCOATED STRAIGHT Disposable Biopsy Forceps - 2.2MM, 50CM, UNCOATED STRAIGHT Disposable Biopsy Forceps - 1.8MM, 104CM, UNCOATED STRAIGHT Disposable Biopsy Forceps - 1.8MM, 50CM, UNCOATED STRAIGHT PROXIMAL REAMER MONOBLOC SZ2 - (CHT) TELIGEN Procedure Kit TELIGEN Procedure Kit Pro TELIGEN System Navigation Ready Instruments TELIGEN Procedure Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MZM Fibrin Sealant Preparation Device General Hospital Class 2 880.5860 2019-09-18
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2024-04-26
HBW Fastener, Plate, Cranioplasty Neurology Class 2 882.5360 2018-12-11
HRX Arthroscope Orthopedic Class 2 888.1100 2018-12-11
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-12-11
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2018-12-11
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2018-12-11
HRX Arthroscope Orthopedic Class 2 888.1100 2018-12-11
HRX Arthroscope Orthopedic Class 2 888.1100 2022-11-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2018-12-11
HRX Arthroscope Orthopedic Class 2 888.1100 2018-12-11
PDU Catheter For Crossing Total Occlusions Cardiovascular Class 2 870.1250 2018-12-11
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2018-12-11
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2021-03-16
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2025-02-04
HTO Reamer Orthopedic Class 1 888.4540 2018-12-11
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-12-11
MZM Fibrin Sealant Preparation Device General Hospital Class 2 880.5860 2018-12-11
HRX Arthroscope Orthopedic Class 2 888.1100 2024-04-26
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-04-26
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2018-12-11
DWZ Device, Biopsy, Endomyocardial Cardiovascular Class 2 870.4075 2018-12-11
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2019-07-10
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2019-07-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-07-22
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2019-07-10

Official Correspondent

David Rose

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Viant Medical, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2954750 Viant Fremont, Inc FREMONT, CA, US
2244012 Viant Medical, Inc S Plainfield, NJ, US
3006194679 Viant Medical SUZHOU EPZ Co., Ltd JIANGSU PROVINCE, CN
3009493875 Viant Medical, Inc. Grand Rapids, MI, US
1832228 Viant AS&O Holdings, LLC Indianapolis, IN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K081051 Spine View, Inc. SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE 2008-08-07
K820777 The Anspach Effort, Inc. MINI-MICRO ARTHROSCOPIC SCAPEL 1982-05-12
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14
K903562 Diasonics, Inc. CW DOPPLER 2.25 MHZ PROBE 1992-03-02
K945318 Tetra Corp. TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA 1995-05-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022 Aesthetics Systems Usa Inc 2
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026 ImaCor Inc. 2
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221485. Last updated year: 2026. Please use registration number 1221485 when referencing this establishment in official correspondence.
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